National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)

The NIH Office of Research on Women's Health (ORWH) and
participating NIH Institutes and Centers invite institutional career
development award applications for Building Interdisciplinary Research
Careers in Women's Health (BIRCWH) Career Development Programs, hereafter
termed "Programs". Programs will support mentored research career
development of junior faculty members, known as BIRCWH Scholars, who have recently
completed clinical training or postdoctoral fellowships, and who will be
engaged in interdisciplinary basic, translational, behavioral, clinical,
and/or health services research relevant to the health of women and, where
appropriate, the use of both sexes to better understand the influence of sex
as a biological variable on health and disease.

This Funding Opportunity Announcement (FOA) allows
appointment of Scholars proposing to serve as the lead investigator of an
independent clinical trial; or proposing a separate ancillary clinical trial;
or proposing to gain research experience in a clinical trial led by another
investigator, as part of their research and career development. The clinical
trial must be a NIH-defined clinical trial. Scholars may also propose
fundamental research or human subjects research that is not a clinical trial.

Key Dates

Posted Date

April 8, 2019

Open Date (Earliest Submission Date)

April 29, 2019

Letter of Intent Due Date(s)

April 29, 2019

Application Due Date(s)

May 29, 2019, by 5:00 PM local time of applicant
organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October-November 2019

Advisory Council Review

January 2020

Earliest Start Date

May 1, 2020

Expiration Date

May 30, 2019

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the Training (T) Instructions
in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The overall goal of the NIH Research Career Development
programs is to help ensure that a diverse pool of highly trained scientists is
available in appropriate scientific disciplines to address the Nation’s
biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The ORWH serves as a focal point for women's health research at the National
Institutes of Health (NIH). The ORWH works
in partnership with the NIH Institutes, Centers and Offices, as well as with
federal agencies, including the Food and Drug Administration, to ensure that
women's health research is an integral part of the scientific framework
throughout the scientific community.

The NIH Office of Research on Women's Health (ORWH) and
participating NIH Institutes and Centers invite institutional career
development award applications for the Building Interdisciplinary Research
Careers in Women's Health (BIRCWH) program. The Building Interdisciplinary
Research Careers in Women's Health (BIRCWH) is an ORWH signature initiative
co-sponsored with multiple NIH Institutes and Centers. This initiative supports
the ORWH mission and advances the 2019-2023 Trans-NIH Strategic Plan for the Health of
Women "Advancing Science for the Health of Women" and its goal to
promote training and careers to develop a well-trained, diverse, and robust
workforce to advance science for the health of women. This program sets the
stage for improved health for women and their families and career opportunities
and advancement for a diverse biomedical workforce. Since the program was
created in 1999, ORWH has awarded over 77 grants to 41 institutions sponsoring
more than 700 women and men as BIRCWH Scholars.

This FOA encourages applications from organizations that
propose creative and innovative institutional research career development
programs in the mission area(s) of the NIH. The program will support mentored
research and career development opportunities of junior faculty, known as
BIRCWH Scholars, who have recently completed clinical training or postdoctoral
fellowships, and who will be engaged in interdisciplinary basic, translational,
behavioral, clinical, and/or health services research relevant to the health of
women and, where appropriate, the use of both sexes to better understand the
influence of sex as a variable on health and disease (NOT-OD-15-102).

Within the framework of this Program's longstanding
commitment to excellence and the projected need for diverse teams to advance
science, attention must be given to recruiting Scholars from racial or ethnic
groups underrepresented in the biomedical, behavioral and clinical sciences,
and individuals with disabilities.

The proposed institutional research career development program may complement
other, ongoing research training and career development programs at the
applicant institution, but the proposed career development experiences must be
distinct from those career development programs currently receiving Federal
support.

Program Objectives

The objectives of this BIRCWH initiative are to increase the
number and skills of investigators through a mentored research and career
development experience leading to an independent scientific career that will
benefit the health of women; advance research on sex/gender influences on
health; and encourage interdisciplinary research methodology. This BIRCWH FOA
will provide opportunities for an interdisciplinary, mentored career
development experience that would otherwise not be available to facilitate the
transition to research independence for junior faculty researchers who are
conducting interdisciplinary research relevant to the health of women.

The BIRCWH Program is built around three pillars:
interdisciplinary research, mentoring, and career development.
Interdisciplinary research, as defined by the National Academy of Sciences
(NAS) in 2008, is a mode of research that integrates information, data,
techniques, tools, perspectives, concepts, and/or theories from two or more
disciplines or bodies of specialized knowledge to advance fundamental
understanding, or to solve problems whose solutions are beyond the scope of a
single discipline or area of research practice. As such, interdisciplinary
science teams work to advance fundamental understanding and solve problems that
those from a single discipline could not.

Interdisciplinary mentoring teams are essential to the
BIRCWH Program, and as such, an inter-professional, team-based approach for
mentoring BIRCWH Scholars is expected. These teams should include mentors from
diverse disciplines to carry out interdisciplinary projects. Team members may
include individuals from medical, dentistry, pharmacy, nursing, biotechnology,
social sciences, anthropology, genetics, and other disciplines representing
different perspectives and areas of expertise. These teams come together to
collaborate as a unit, with the common goal of supporting a BIRCWH Scholar in
the transition from trainee to independent researcher. In this funding
opportunity announcement (FOA), the interdisciplinary team approach is applied
to the study of the health of women across the lifespan, bridging basic and
clinical science and incorporating new models of collaboration and
institutional support. Proposed Programs must ensure the integration of
interdisciplinary mentoring teams.

Note:
This Funding Opportunity Announcement (FOA) allows appointment of Scholars
proposing to serve as the lead investigator of an independent clinical trial;
or proposing a separate ancillary clinical trial; or proposing to gain research
experience in a clinical trial led by another investigator, as part of their
research and career development. The clinical trial must be a NIH-defined
clinical trial. Scholars may also propose fundamental research or human
subjects research that is not a clinical trial.

The ORWH and partner components intend to commit an
estimated total of $5.5M, for fiscal year 2020. Future year amounts will
depend on annual appropriations.

Award Budget

Applicants may request no more than $600,000 in direct
costs.

Award Project Period

The scope of the proposed project should determine the
project period. The maximum project period is 5 years.

Other Award Budget
Information

Personnel Costs

Individuals designing, directing, and implementing the
career development program may request salary and fringe benefits appropriate
for the person months devoted to the program. Salaries requested may not
exceed the levels commensurate with the institution's policy for similar
positions and may not exceed the congressionally mandated cap. If mentoring
interactions and other activities with Scholars are considered a regular part
of an individual's academic duties, then mentoring and other interactions
with Scholars are non-reimbursable from grant funds.

The salaries of administrative and clerical staff should
normally be treated as indirect (F&A) costs. Direct charging of these
costs may be appropriate only if all of the following conditions are met: (1)
Administrative or clerical services are integral to a project or activity;
(2) Individuals involved can be specifically identified with the project or
activity; (3) Such costs are explicitly included in the budget or have the
prior written approval of the Federal awarding agency; and (4) The costs are
not also recovered as indirect costs. When specifically identified and
justified, these expenses must be itemized in Sections A and B, as
appropriate, of the R&R Budget.

A Research Director may be appointed to perform day-to-day
administration and management of the award. This should be an experienced
investigator with skills and qualifications complementing those of the PD/PI.
Salary and fringe benefits for the Research Director, if any, up to 1.2
person months may be requested. Also, salary and fringe benefits up to 6
person months effort for a program assistant may be requested; the level of
effort may be adjusted. If the PD/PI elects to delegate the day-to-day
administration and management of the award to a separate Research Director,
then compensation will not be provided for the PD/PI.

Scholar Costs

Scholars are those individuals who benefit from the
proposed activities and experiences involved in the career development
program. Scholar costs must be justified as specifically required for the
proposed career development program and based on institutional policies for
salaries paid to individuals in similar positions, regardless of the source
of funds. These expenses must be itemized in the proposed budget.

Salary: BIRCWH Scholars’ salary and fringe support is
intended to offset only that portion of the salary that is devoted to
research and career development. Each Scholar may be provided salary
support up to $100,000 total costs, plus fringe benefits per grantee
institutional policy, annually.

Research and Career Development Support: Within each
BIRCWH Scholar's total award, the budget must include funds for research and
career development support in an amount between $25,000 and $50,000. Research
and career development costs may include the following expenses: (1) tuition
and fees related to career development; (2) research expenses, such as
supplies, equipment, and technical personnel; (3) travel to training or
scientific meetings other than the annual BIRCWH meeting; (4) statistical
services including consultant costs and computer time; and (5) other project
infrastructure including relevant secondary data sets.

Patient care costs such as inpatient bed days or
outpatient visits, except for clinical laboratory analyses essential for the
Scholars' research, will not be supported with K12 funds.

At any point in time, there can be no more than three (3)
BIRCWH Scholars supported on the grant.

Other Program Related Expenses

Shared consultant, equipment, and supply costs, travel for
key persons, and other program-related expenses such as guest speaker fees
and/or honoraria may be included in the proposed budget. These expenses must
be justified as specifically required by the proposed program and must not
duplicate items generally available at the applicant institution.

With strong justification, a shared Resource Laboratory
may be requested as part of the Program, within the total budget. Such a
resource must be a new entity, not an extension or enhancement of an existing
facility. The Shared Resource Laboratory might include scientific services
such as, but not limited to, assays, molecular biology or biostatistics.
Requests for this Resource Laboratory must be justified in terms of
cost-effective enhancement of the research resources that will serve the
three BIRCWH Scholars' projects.

Travel to an annual BIRCWH meeting for the PD/PI, Research
Director, and current Scholars must be requested in this application. Travel
to the annual BIRCWH meeting for Scholars should not come from their research
support. Travel of the PD/PI, Program Director, or program mentors to
scientific meetings other than the annual BIRCWH meeting will not be
supported with K12 funds.

Indirect Costs

Indirect Costs (also known as Facilities &
Administrative [F&A] Costs) are reimbursed at 8% of modified total direct
costs (exclusive of tuition and fees, consortium costs in excess of $25,000,
and expenditures for equipment), rather than on the basis of a negotiated
rate agreement.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made from this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher
Education Institutions are always encouraged to apply for NIH support as Public
or Private Institutions of Higher Education:

The sponsoring institution must assure support for the
proposed program. Appropriate institutional commitment to the program includes
the provision of adequate staff, facilities, and educational resources that can
contribute to the planned program.

The applicant institution
must have a strong and high-quality
research program in the area(s) proposed under this FOA and must have the
requisite faculty, staff, potential Scholars and facilities on site to conduct the proposed institutional program. In
many cases, it is anticipated that the proposed program will complement other
ongoing career development programs occurring at the applicant institution and
that a substantial number of program faculty will have active research projects
in which participating Scholars may gain relevant experiences consistent with
their research interests and goals.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number to register in eRA Commons. Organizations can
register with the eRA Commons as they are working through their SAM or
Grants.gov registration, but all registrations must be in place by time of
submission. eRA Commons requires organizations to identify at least one Signing
Official (SO) and at least one Program Director/Principal Investigator (PD/PI)
account in order to submit an application.

Grants.gov – Applicants must
have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons.If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with
the skills, knowledge, and resources necessary to carry out the proposed research training program as the
Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

The PD/PI should be an established investigator in the
scientific area in which the application is targeted and capable of providing
both administrative and scientific leadership to the development and
implementation of the proposed program. The PD/PI will be responsible for the
selection and appointment of Scholars to the approved career development
program, and for the overall direction, management, administration, and
evaluation of the program. The PD/PI will be expected to monitor and assess the
program and submit all documents and reports as required. Unless a separate
Research Director position is proposed, the PD/PI has responsibility for the
day to day administration of the program and is responsible for appointing
members of the required Advisory Committee, using their recommendations to
determine the appropriate allotment of funds.

Applicant organizations may submit more than one application,
provided that each application is programmatically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Preceptors/Mentors

Program
faculty should have strong records as researchers, including recent
publications and successful competition for research support in the area of the
proposed career development program. Program faculty should also have a record of career
development, including
successful, former junior faculty who have established productive, independent
research careers relevant
to the NIH mission. Researchers from diverse backgrounds, including
racial and ethnic minorities, persons with disabilities, and women are
encouraged to participate as mentors.

Mentors from collaborating departments are expected to have
the requisite research expertise relevant to the health of women and sex and
gender influences. If relevant to the proposed program, mentors should also
have research expertise on factors that contribute to disparities in health
status or health outcomes for different populations of women.

Scholars

Scholars to be supported by the institutional career
development program must be at the career level for which the planned program
is intended. Scholars are expected to devote a minimum of 9 person-months (75%
of full-time professional effort) or at least 6 person-months for surgical
specialties, during the appointment on the K12 award, except as noted in NOT-OD-18-157.

Scholars must be citizens or
noncitizen nationals of the United States or have been lawfully admitted for
permanent residence at the time of appointment. Additional details on
citizenship requirements are available in the NIH
Grants Policy Statement.

At the time of appointment, BIRCWH Scholars must:

Have a clinical doctorate or Ph.D. degree or its equivalent.

Have completed any postgraduate training normally expected for a
faculty appointment in their field (including clinical or postdoctoral
fellowship training, or residency if they have chosen not to subspecialize).

Have no more than six years of research or research training experience
beyond their last doctoral degree.

Have been assigned mentors with extensive research experience
relevant to the Scholars' individual research and career development goals.

Not be or have been a PD/PI on a Center (P50, P60, P20, P30, U54)
grant or subproject of a Program Project (P01), individual career development
(K-series) award, or independent research project grant awards (R01) or equivalent.

In keeping with the type of mentoring and career development
being provided by the K12, a Scholar who is competitive for P01 or R01 grant support
is likely to be too senior for the BIRCWH program.

At any point in time, there cannot be more than three (3)
BIRCWH Scholars supported by grant funds.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

The application forms package specific to this opportunity
must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system
solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your
administrative office for instructions if you plan to use an institutional
system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) Instructions
in the SF424
(R&R) Application Guide except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

Instructions
for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

Follow all instructions provided in the SF424 (R&R)
Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R)
Application.

SF424 (R&R) Other Project Information

Follow all instructions provided in the SF424 (R&R) Application,
with the following additional modifications:

Substitute
the term “Scholars” for all references to
“trainees” in the SF424 (R&R) Application Guide, and substitute the term
“career development” for all references to “training” in the SF424 (R&R)
Application Guide.

Project
Summary/Abstract. Provide an abstract of the entire application.
Include the objectives, rationale and design of the career development program,
as well as key activities in the career development plan. Indicate the plannedduration of appointments, the projected number of Scholars including their
levels (i.e., assistant professor, tenure-track, ), and intended Scholar
outcomes. Detail plans for the evaluation of the program and Scholar outcomes.

Other
Attachments.An Advisory Committee is a required component of a career development program. Provide a plan for
the appointment of an Advisory Committee to monitor Scholar recruitment
and selection, and to monitor the overall progress of the career development program. The composition, roles,
responsibilities, and desired expertise of committee members, frequency of
committee meetings, and other relevant information should be included. Describe
how the Advisory Committee will evaluate the overall effectiveness of the
program. Proposed Advisory Committee members should be named in the application
if they have been invited to participate at the time the application is
submitted. Renewal applications with Advisory Committees should include
the names of all committee members during the past project period. Please name
your file “Advisory_Committee.pdf”.

The
filename provided for each “Other Attachment” will be the name used for the
bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R)
Application.

Research Director. The PD/PI of the application may also
serve as the Research Director with responsibility for the day-to-day
operations of the Program. Alternatively, the application may designate an
individual other than the PD/PI to serve as Research Director. If the Research
Director is an individual other than the PD/PI, a biographical sketch including
the description of the Research Director's scientific expertise relevant to the
application, leadership, and administrative capabilities essential to
coordinate a program for developing investigators must be included in the
application.

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R)
Application.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R)
Application Guide, with the following additional modifications:

Research and Related (R&R) Budget

Follow all instructions provided in the SF424 (R&R)
Application Guide with the following additional modifications:

Include all personnel other than the Training PD(s)/PI(s) in the
Other Personnel section, including clerical and administrative staff. Also
include proposed salary costs for planned Scholars.

Do not complete the section on Participant/Trainee Support Costs.

The applicant institution may request support for three Scholars
in each budget period.

With strong justification, a shared Resource Laboratory may be
requested as part of the Program, within the total budget. Such a resource must
be a new entity, not an extension or enhancement of an existing facility. The
Shared Resource Laboratory might include scientific services such as, but not
limited to, assays, molecular biology or biostatistics. Requests for this
Resource Laboratory must be justified in terms of cost-effective enhancement of
the research resources that will serve the three BIRCWH Scholars' projects.

The salaries and laboratory costs of the mentors may not come
directly from the K12 grant.

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised
of the following sections:

Training Program

Faculty, Trainees, and Training Record

Other Training Program Sections

Appendix- Note that the Appendix should only be used in
circumstances covered in the NIH policy on appendix materials or if the FOA
specifically instructs applicants to do so.

Follow all instructions provided in the SF424 (R&R)
Application Guide with the following additional modifications:

Particular attention must be given to the required Training
Data Tables. Data Tables 1, 2, 4, 6B, 7, 8C are required for this
application. No other Data Tables may be submitted. Applicants should summarize,
in the body of the application, key data from these required tables as these
factors contribute to the overall environment of the program.

Training Program

Program
Plan

Program
Administration.

Describe plans for administering the overall program
including immediate and long-term objectives of the program, and the proposed
strategy and structure for monitoring the program, including any planned
courses, seminars, workshops, and any activities designed to enhance program
effectiveness.

Institutions with existing career development programs
must explain what distinguishes this program from the others, how their
programs will synergize with one another, if applicable, and provide evidence
that the pool of faculty, potential Scholars, and resources are robust enough
to support additional programs. When a research director position is planned, a
description of the scientific expertise, leadership, and administrative
capabilities essential to coordinate a program for developing investigators must
be included in the application.

Applicants should provide their plan(s) for the
recruitment of Scholars, as well as Scholar review and selection procedures.
Scholar appointments are limited to three (3) Scholars at any point in time,
and should be based on the recommendation of the Advisory Committee. Scholars
are appointed in 12-month appointments, renewable in annual increments up to
five years total, and is contingent upon satisfactory progress as reported to
the Advisory Committee. A total of two to three years of consecutive support
on this K12 program is considered optimal. Circumstances where less than two
years of support is likely to occur include early promotion or other career
development milestones reached earlier than expected.

Any crucial details of the program evaluation plan
not included under Other Attachments (Section IV.2)
should be captured in this Program Plan.

In the event that a clinical trial is proposed, provide
documentation of the PD/PI(s) expertise, experience, and ability to oversee the
organization, management and implementation of the clinical trial.

Career
Development

Applicants must propose a comprehensive career
development plan that has: (1) intrinsic research importance relevant to the
health of women; (2) will serve as a suitable vehicle for learning the
methodology, theories, and concepts needed for a well-trained, independent
interdisciplinary researcher in an area relevant to women's health and/or sex
and gender differences research; and (3) ensure high research productivity.
This comprehensive plan should clearly show how the purpose and objectives meet
the broader research priorities identified by the NIH Office of Research on
Women's Health to support the career development of junior faculty who are
conducting interdisciplinary research relevant to the health of women. The plan
should also include a description of the professional development skills
training and career guidance to be provided to Scholars, including training in
the consideration of SABV, grantsmanship and other training to apply
successfully for career development or independent research support during the
course of K12 support. More details about Sex as a Biological Variable (SABV)
can be found at: https://orwh.od.nih.gov/sex-gender/nih-policy-sex-biological-variable.

The description should include a plan to assign each Scholar
a minimum of two mentors from different disciplines and training backgrounds,
to form an interdisciplinary mentoring team. The Scholars' research experiences
may include basic, behavioral, translational, clinical, and/or health services
research approaches to biomedical or behavioral problems relevant to the health
of women. It is required that assigned mentors will interact closely with the
Scholar and provide guidance to develop a tailored career development plan,
which may include the use of a formal Individual
Development Plan (IDP) with individually tailored milestones.

Proposed
Training.

In the event that a clinical trial may be proposed, provide
documentation of the administrative, data coordinating, enrollment and
laboratory/testing centers appropriate for the clinical trial, including any
feasibility or ancillary study.

For renewal
applications, highlight how the training program has evolved in response to
changes in relevant scientific and technical knowledge, educational practices,
and to evaluation of the career development program.

Institutional
Environment and Commitment to the Program.

The sponsoring institution must assure support for
the proposed program including assurance that sufficient time will be allowed
for the PDs/PIs and other Program Faculty to contribute to the proposed program,
and that there will be protected time for Scholars (9 person months, equivalent
to 75%, or at least 6 person months for surgical specialties) selected for the
program.

Plan for Instruction in the Responsible Conduct of
Research

Individuals are required to comply with the
instructions for Plan for Instruction in the Responsible Conduct of Research as
provided in the SF424 (R&R) Application Guide.

Program
Faculty.

If any mentors will supervise a Scholar (K12)
proposing to either lead a clinical trial, or gain research experience in a
clinical trial, provide documentation of his/her expertise, experience, and ability
to provide guidance in the organization, management and implementation of the
proposed clinical trial, ancillary, or feasibility study and help him/her to
meet the study timelines.

Scholar
Candidates.

If the event that a clinical trial may be proposed, discuss
the potential of the prospective Scholar(s) to organize, manage, and implement
the proposed clinical trial, feasibility or ancillary study.

Appendix

Limited items are allowed in the Appendix.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide; any instructions provided here are in addition to theSF424
(R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional modifications:

Study
Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record
will result in a validation error.

Delayed
Onset Study

Note: Delayed
onset does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).

If you answered “Yes” to the question “Are Human Subjects
Involved?” on the R&R Other Project Information form, you must complete a
Delayed Onset Study.

If you check the “Anticipated Clinical Trial” box within
your Delayed Onset Study, then the Justification attachment must acknowledge
that additional clinical trial information will be provided to the awarding
component before any appointee begins independent clinical trial research.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO Commercial
and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date and time. If a Changed/Corrected application is submitted
after the deadline, the application will be considered late. Applications that
miss the due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants are
responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time
submission are provided in the SF424 (R&R) Application Guide.

All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH
Grants Policy Statement. Any
additional costs associated with the decision to allow research elective credit
for short-term research training are not allowable charges on an institutional
training grant.

7. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper
applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit How to
Apply – Application Guide. If you encounter a system issue beyond your control
that threatens your ability to complete the submission process on-time, you
must follow the Dealing
with System Issues guidance. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package.Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review and responsiveness by components
of participating organizations, NIH. Applications that are incomplete, non-compliant
and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to
notify the ORWH Referral Office by email at beggl@od.nih.gov when the
application has been submitted. Please include the FOA number and title, PD/PI
name, and title of the application.

Post Submission Materials

Applicants are
required to follow the instructions for post-submission materials, as described
in the
policy. Any instructions provided here are in addition to the instructions
in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review
system.

Overall Impact

Reviewers
will provide an overall impact score to reflect their assessment of the
likelihood that the proposed career
development program will prepare individuals for
successful, productive scientific research careers and thereby exert a
sustained influence on the research field(s) involved, in consideration of the following
review criteria and additional review criteria (as applicable for the project
proposed).

Scored Review Criteria

Reviewers will consider each
of the review criteria below in the determination of the merit of the training
program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the
context of proposed short-term training. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Career Development Program
and Environment

Does the proposed program clearly outline a plan to
recruit and develop well-qualified junior investigators for successful
careers as biomedical or clinical researchers?

Is there evidence of an adequate pool of potential Scholars
who could benefit from receiving career development support?

Are the content and duration of any proposed didactic,
training-related, and research-related activities of the program
appropriate?

Are appropriate timelines indicated for career progression
and transition to independence?

Does the institutional environment (e.g., research
facilities and other relevant resources) in which the program will be
conducted contribute to the probability of success?

Does the proposed career development program benefit from
unique features of the scientific environment, subject populations, or
employ useful collaborative arrangements?

Is the institutional commitment to the proposed program
appropriate?

If multiple sites are participating, is this adequately
justified in terms of the career development and research experiences
provided?

Is there sufficient assurance that the required effort of
the PD/PI, mentors and Scholars will be devoted directly to the career
development and related activities?

When applicable, is there adequate documentation describing the
responsibilities of the advisory committee with regard to the provision of
input, guidance and oversight of the program?

Is there a plan to provide a tailored career development plan and
interdisciplinary mentoring team for each Scholar, designed with respect to the
Scholar's background, level of research experience, proposed research focus,
and goals?

Is the proposed career development plan likely to prepare Scholars
to submit individual career development or independent grant applications
during the course of their K12 support?

If clinical trials may be proposed, are the administrative, data
coordinating, enrollment and laboratory/testing centers, appropriate for the
trial proposed? Does the application adequately address the capability and
ability to conduct the trial feasibility or ancillary study at the proposed
site(s) or centers? If applicable, are the plans to add or drop enrollment
centers, as needed, appropriate? If international site(s) is/are proposed, does
the application adequately address the complexity of executing the clinical
trial? If multi-sites/centers, is there evidence of the ability of the
individual site or center to: (1) enroll the proposed numbers; (2) adhere to
the protocol; (3) collect and transmit data in an accurate and timely fashion;
and, (4) operate within the proposed organizational structure?

Career Development Program
Director(s)/Principal Investigator(s) (PD(s)/PI(s))

With regard to the proposed leadership for the program, do the
PD/PI(s) have the expertise, experience, and ability to oversee the
organization, management and implementation of the proposed clinical trial?

Do the PD/PI and Research Director (if applicable) have the
experience to develop, direct and administer the proposed program?

Does the leadership team bring complementary and integrated
expertise to the program? Is there evidence that an appropriate level of effort
will be devoted by the program leadership to ensure program objectives?

Are the research qualifications, scientific stature, previous
leadership and mentoring experience, and track record(s) appropriate for the
proposed career development program?

Are the PD(s)/PI(s) currently engaged in research relevant to the
scientific area of the proposed program?

For applications designating multiple PDs/PIs:

· Is a
strong justification provided that the multiple PD/PI leadership approach will
benefit the career development program and the Scholars?

· Is a
strong and compelling leadership approach evident, including the designated roles
and responsibilities, governance, and organizational structure consistent with
and justified by the aims of the career development program and the
complementary expertise of the PDs/PIs?

Mentors

Do the
mentors have appropriate expertise and experience, as well as track
records of past mentoring and training?

Are the
quality and extent of the mentors’ roles in providing guidance and
scientific advice to the Scholars acceptable? Are the mentors currently
engaged in relevant research?

Is
there a sufficient number of mentors in complementary fields to form the
requisite interdisciplinary mentoring teams?

Do the preceptors/mentors who will supervise the Scholar(s) have
the expertise, experience, and ability to provide guidance in the organization,
management and implementation of a clinical trial, ancillary, or feasibility
study and help him/her to meet timelines?

Scholars

Is a recruitment plan proposed with strategies likely to attract
high quality Scholars?

Are there well-defined and well justified recruitment and
selection strategies?

Is there evidence of a sufficiently large, competitive Scholar
pool to warrant the proposed size of the career development program?

Are the content, phasing, and proposed duration of the career
development plan appropriate for achieving scientific independence of the Scholars?

What is the likelihood that the career development plan will
contribute significantly to the scientific development of the Scholars?

Does the plan for selection of the Scholars include all of the eligibility
criteria stated in the FOA?

Do prospective Scholars have the potential to organize, manage,
and implement the proposed clinical trial, feasibility or ancillary study?

Are there plans to provide instruction in data management and
statistics including those relevant to clinical trials to the prospective Scholars?

Training
Record

Is there evidence of a successful past training record of the
PD/PI and mentors, including the success of former Scholars in seeking
independent support and establishing productive scientific careers?

Does the program have a rigorous evaluation plan to assess the
quality and effectiveness of the training?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for
Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets
the criteria for one or more of the six categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials. For additional information on review of the Human Subjects section,
please refer to the Guidelines
for the Review of Human Subjects.

Inclusion of
Women, Minorities, and Children

When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed
plans for the inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of
children to determine if it is justified in terms of the scientific goals and
research strategy proposed. For additional information on review of the
Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period, including on the Recruitment Plan to
Enhance Diversity, and Training in the Responsible Conduct of Research. Does
the application describe the program’s accomplishments over the past funding
period(s)? Are changes proposed that would improve or strengthen the career
development experience? Is there evidence of a successful past training record
of the PD/PI and mentors, including the success of former Scholars in seeking
independent support and establishing productive scientific research careers?

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Recruitment
Plan to Enhance Diversity

Peer
reviewers will separately evaluate the recruitment plan to enhance diversity
after the overall score has been determined. Reviewers will examine the
strategies to be used in the recruitment of individuals from underrepresented
groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and
the consensus of the review committee will be included in an administrative
note in the summary statement.

Training in the
Responsible Conduct of Research

All applications for support under this FOA must
include a plan to fulfill NIH requirements for instruction in the Responsible
Conduct of Research (RCR). Taking into account the specific characteristics of
the career development program, the level of Scholar experience, and the
particular circumstances of the Scholars, the reviewers will evaluate the
adequacy of the proposed RCR training in relation to the following five
required components: 1) Format - Does the plan satisfactorily
address the format of instruction, e.g., lectures, coursework and/or real-time
discussion groups, including face-to-face interaction? (A plan involving
only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as
conflict of interest, authorship, data management, human subjects and animal use,
laboratory safety, research misconduct, research ethics? 3) Faculty
Participation - Does the plan adequately describe how faculty will
participate in the instruction? For renewal applications, are all training
faculty who served as course directors, speakers, lecturers, and/or discussion
leaders during the past project period named in the application? 4) Duration
of Instruction - Does the plan meet the minimum requirements for RCR,
i.e., at least eight contact hours of instruction? 5) Frequency of Instruction
– Does the plan meet the minimum requirements for RCR, i.e., at least
once during each career stage (undergraduate, post-baccalaureate, predoctoral,
postdoctoral, and faculty levels) and at a frequency of no less than once every
four years?

For renewal
applications, does the progress report document acceptable RCR instruction in
the five components described above? Does the plan describe how participation
in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction
proposed in response to feedback and in response to evolving issues related to
responsible conduct of research?

Plans and past
record will be rated as ACCEPTABLE or UNACCEPTABLE, and the
summary statement will provide the consensus of the review committee.

Select Agent
Research

Reviewers will assess the information provided in
this section of the application, including (1) the Select Agent(s) to be used
in the proposed research, (2) the registration status of all entities where
Select Agent(s) will be used, (3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and (4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the NIH
Center for Scientific Review in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response
to this FOA.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications submitted in response to this FOA. Following
initial peer review, recommended applications will receive a second level of
review by the Eunice Kennedy Shriver National Advisory Council of the Child
Health and Human Development. The following will be considered in making
funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and
conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Individual awards are based on the application submitted to,
and as approved by, the NIH and are subject to the IC-specific terms and
conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more
clinical trials by law (Title VIII, Section 801 of Public Law 110-85), the
"responsible party" must register and submit results information for
certain “applicable clinical trials” on the ClinicalTrials.gov Protocol
Registration and Results System Information Website (https://register.clinicaltrials.gov).
NIH expects registration of all trials whether required under the law or not.
For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/.

Institutional Review Board or Independent Ethics Committee
Approval: Grantee institutions must ensure that all protocols are reviewed by
their IRB or IEC. To help ensure the safety of participants enrolled in
NIH-funded studies, the awardee must provide NIH copies of documents related to
all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for
data and safety monitoring requires oversight and monitoring of all
NIH-conducted or -supported human biomedical and behavioral intervention
studies (clinical trials) to ensure the safety of participants and the validity
and integrity of the data. Further information concerning these requirements is
found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption
Requirements: Consistent with federal regulations, clinical research projects
involving the use of investigational therapeutics, vaccines, or other medical
interventions (including licensed products and devices for a purpose other than
that for which they were licensed) in humans under a research protocol must be
performed under a Food and Drug Administration (FDA) investigational new drug
(IND) or investigational device exemption (IDE).

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color, national
origin, disability, age and, in some circumstances, sex and religion. This
includes ensuring your programs are accessible to persons with limited English
proficiency. HHS recognizes that research projects are often limited in scope
for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself that
a Federal agency previously entered and is currently in FAPIIS. The Federal
awarding agency will consider any comments by the applicant, in addition to
other information in FAPIIS, in making a judgement about the applicant’s
integrity, business ethics, and record of performance under Federal awards when
completing the review of risk posed by applicants as described in 45 CFR Part
75.205 “Federal awarding agency review of risk posed by applicants.” This
provision will apply to all NIH grants and cooperative agreements except
fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required
to submit the Research
Performance Progress Report (RPPR) annually. Continuation support will not
be provided until the required forms are submitted and accepted.

Failure by the grantee institution to submit required forms
in a timely, complete, and accurate manner may result in an expenditure
disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Other Reporting Requirements

The institution must submit a completed Statement of Appointment (PHS Form
2271) for each Scholar appointed or reappointed for eight weeks or more.
Grantees must submit the PHS 2271 data electronically using the xTrain system.
More information on xTrain is available at xTrain (eRA
Commons). An appointment or reappointment may begin any time during the
budget period, but not before the budget period start date of the grant year.

A notarized statement verifying possession of permanent residency
documentation must be submitted with the Statement of Appointment (PHS Form
2271). Individuals with a Conditional Permanent Resident status must first
meet full (non-conditional) Permanent Residency requirements before receiving
support.

Termination Notice: Within 30 days of the end of the total
support period, the institution must submit a Termination Notice (PHS Form
416-7) via xTrain for each Scholar appointed for eight weeks or more.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or performance
of a Federal award that reached final disposition within the most recent
five-year period. The recipient must also make semiannual disclosures
regarding such proceedings. Proceedings information will be made publicly
available in the designated integrity and performance system (currently
FAPIIS). This is a statutory requirement under section 872 of Public Law
110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public
Law 111-212, all information posted in the designated integrity and performance
system on or after April 15, 2011, except past performance reviews required for
Federal procurement contracts, will be publicly available. Full reporting
requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award
Term and Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

The overall evaluation of the program will be based on
metrics that will include, but are not limited to, the following:

For
programs involving early career investigators:

Subsequent participation in a formal career development program
in a STEM field

Subsequent participation in research or employment in a STEM
field

Authorship of scientific publications in a STEM field

Subsequent independent research grant support from NIH or another
source

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

For PAR with special review arrangements and RFA only,
replace the text block with exactly the same formatted information as shown for
Scientific/Research Contact(s) and Financial/Grants Management Contact(s).